• Posted: December 22, 2015

Data Sharing Lexicon

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About This Work Product

Sharing of genomic and health data is increasingly international, but must contend with discrepancies in the terms employed by applicable laws, ethics policies and regulatory systems. The purpose of this GA4GH Data Sharing Lexicon is to support international data sharing by promoting common/concordant terms within the GA4GH and across jurisdictions and research contexts with the ultimate aim of improving human health.

This Data Sharing Lexicon is a tool developed to promote data-sharing in general. It is not intended to focus on biobanking or the transfer or processing of tissues or samples. The terms included are predominantly derived from legal/regulatory sources but modified so that they are applicable to many jurisdictions. These terms are not intended to replicate definitions found in particular statutes, or within scientific and technical literatures. Additional resources can be found in the attached bibliography.

Where relevant, the Data Sharing Lexicon builds on terminology used in GA4GH documents and policies. It also incorporates terms already in use in existing GA4GH glossaries where these are relevant and appropriate.

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Work Product Details

Topics:

  • Privacy
  • Policy
  • access
  • law
  • regulation
  • accountability

Team

  • Alison Hall , PHG Foundation , Cambridge, United Kingdom - Lead
  • Anne Cambon-Thomsen , National Institute of Health and Medical Research , Toulouse, France
  • Clement Yongxi Chen , University of Hong Kong , Hong Kong, China
  • Alea Garbagnati , Roche , San Francisco, United States
  • Elli Gourna , University of Leicester , Leicester, United Kingdom
  • Jennifer Harris , Norwegian Institute of Public Health , Oslo, Norway
  • Emily Kirby , P3G , Montreal, Canada
  • Bartha Knoppers , Centre of Genomics and Policy , Montreal, Canada
  • Laura Lyman Rodriguez , National Human Genome Research Institute , Washington, D.C, United States
  • Howard Simkevitz , Ontario Institute for Cancer Research , Toronto, Canada
  • Anne-Marie Tassé , P3G , Montreal, Canada
  • Adrian Thorogood , McGill University / Université McGill , Montreal, Canada
  • Susan Wallace , University of Leicester , Leicester, United Kingdom

Data Sharing Lexicon - Read Online

Global Alliance for Genomics & Health Data Sharing Lexicon

Term Definition
Accountability The obligation to explain and justify conduct.
Anonymisation The irreversible delinking of identifying information from associated data.
Audit A systematic review to evaluate adherence to applicable laws and policies.
Big Data Large and complex datasets typically combining multiple sources of information and analyzed through novel computational methods.
Biobank An organized collection of human biological material and associated data which is stored, processed and searchable.
Clinical Trial A study involving human participants to investigate the efficacy and/or safety of one or more medicines or other health-related interventions.
Cloud Computing Shared computing resources accessible over the internet that can include capabilities for processing and storing data.
Coding/Pseudonymisation The act of replacing an identifier with a code for the purpose of avoiding direct identification of the participant, except by persons holding the key linking the code and identifier.
Cohort A group of individuals identified by common characteristic(s) (e.g., demographic, exposure, illness) or studied over time using a common protocol.
Confidentiality The ethical and legal obligation of an individual or organization to safeguard data or information by controlling access as authorized by law or by the data donor.
Conflict of Interest One or more connections or interests (personal, social, financial or professional) that influence, or could be perceived to influence, professional integrity and independence.
Consent Voluntary and informed expression of the will of a person, or if incompetent, his/her legal representative.
Controlled Restricted Access Access to data that is subject to conditions and an approval process. Data Observations, narratives or measurements that are assumed as the basis for further analysis, calculation or reasoning.
Data Access Committee A committee that reviews and authorizes applications for data access and use.
Data Breach The unauthorized collection, access, use, disclosure or release of data.
Data Curation The process of selecting, annotating, maintaining, archiving and tracking data.
Data Donor The individual whose data have been collected, held, used and shared.
Data Embargo Defined period of time when data are unavailable for wider access.
Data Linkage The process by which records representing the same entity or individual are linked across multiple data sources.
Data Protections The set of laws, policies and procedures that aim to minimize intrusion into people’s privacy, uphold confidentiality, and penalize undue intrusions and/or breaches.
Data Security The protection of the confidentiality, availability and integrity of data.
Data Sharing Extending access to data for the purpose of research or analyses.
Data Steward An entity responsible for assuring the quality, integrity, and access arrangements of data and metadata in a manner that is consistent with applicable law, institutional policy, and individual permissions.
Data (or Material) Transfer Agreement A binding legal agreement between the provider and the recipient of data (or materials) that sets forth conditions of transfer, use and disclosure.
Database Data and information that are managed and stored in a systematic way to enable data analyses.
Dataset A collection of data which may be a subset in a database.
De-identification The removal or alteration of any data that identifies an individual or could, foreseeably, identify an individual in the future.
Destroy To take all necessary steps to ensure that data are no longer stored or able to be used.
Disclosure The revelation of confidential information about an individual.
Disclosure Risk The probability of confidential information being revealed about an individual.
Encryption A mechanism of safeguarding stored data or information by making those data or information unreadable without access to the correct decryption method.
Ethical Guidelines A framework to guide decision-making based on accepted ethical principles and practice.
Ethics review committee/ IRB/ REC/REB An independent committee for the ethical review of research activities.
Governance The process of policy making and management that guides and oversees research in a consistent and structured manner.
Harmonization The process of unifying certain policies, methodologies and approaches in order to achieve interoperability.
Identifiable/ Personal Data Data that alone or in combination with other data may reasonably be expected to identify an individual.
Identity and Access Management A set of processes and supporting technologies that enable the creation, maintenance, use, and revocation of digital identity.
Incidental Findings A finding discovered in the course of clinical care or research concerning an individual that is beyond the aims of the clinical care or research.
Individual Research Results A finding discovered in the course of research concerning an individual that relates to the aims of the research.
Information Data that have already been interpreted, i.e. they have meaning in a specific context.
Legacy Data or Biospecimens Data (or biospecimens) previously collected for research or for clinical care, where new proposed uses may not be covered.
Medical/Health Record A paper or electronic record created in the health care system which contains medical and health-related information about an individual and is used to record and support health care for that individual.
Metadata Data that describe other data.
Open Data Access Making data available without restriction.
Opt-in A consent mechanism where an active choice is made to participate.
Opt-out A consent mechanism where consent is implied unless an active choice is made not to participate.
Personal Data/ Identifiable Data Data that alone or in combination with other data may reasonably be expected to identify an individual.
Privacy The right and freedom to control access to information about oneself.
Pseudonymisation/Coding The act of replacing an identifier with a code for the purpose of avoiding direct identification of the participant, except by persons holding the key linking the code and identifier.
Public Domain The body of knowledge and innovation in relation to which no person or other legal entity can establish or maintain proprietary interests.
Public Engagement An inclusive act ranging from the active involvement of a population or sub-population in the development, management or governance of a project, to the provision of information and raising awareness of a project.
Quality Conformity of data, biospecimens or processes with pre-established specifications appropriate to the purpose to which the data, biospecimens or processes will be put.
Registered Access A system of authentication and self-declaration prior to providing access to data.
Re-Identification The act of associating specific data or information within a dataset with an individual.
Return of Results Communication of research results to an individual or a designated health care provider or family member.
Risk The probability that an event, favorable or adverse, will occur within a defined time interval.
Safe Haven A repository in which data are stored and accessed in ways that maintain their integrity and quality whilst meeting relevant ethical and legal controls on their use and dissemination.
Secondary uses Using data or biospecimens in a way that differs from the original purpose for which they were generated or collected.
Supervisory Authority The public authority (or authorities) in a given jurisdiction responsible for monitoring the application of law and administrative measures adopted pursuant to data privacy, data protection and data security.
Surveillance The systematic collection, monitoring and dissemination of health data to assist in planning, implementation and evaluation of an action or intervention such as research or public health.
Traceability The ability to verify the history, location, or application of an item, by means of documented recorded identification. For a biospecimen this pertains to any step of its handling, including donation, collection, processing, testing, storage, and disposition.
Trusted Third Party An individual or organization that safeguards access to information linking individuals to their data and biospecimens.
Vulnerable Persons / Populations Individuals or groups requiring special considerations and/or under the protection of governments, institutions or legal representatives including but not limited to children, the elderly, and those with mental health issues.

Acknowledgements

This Policy is the result of the work of many people and committees. Developed under the auspices of the GA4GH’s Regulatory and Ethics Working Group, the Policy was formulated by an international committee (Data Sharing Lexicon Task Team) representing a wide spectrum of the law, security, bioethics, genomics, and life science industry communities. Collaborative input was provided from individuals as well as biomedical, patient advocacy, and ethical, policy and legal organizations, committees, and projects from all regions of the world.

Appendix 1: Table of Concordance of Data Privacy and Security Terms1
(from GA4GH Privacy and Security Policy)

Spectrum of Identifiability

1 (Most identifiable)
“Is or can be fully identifiable to everyone”
2
“Is unidentifiable to most, but remains
re-identifiable to those with access to the key(s)”
3
“Is likely no longer identifiable to anyone”
4 (Least identifiable)
“Never was identifiable”
  • identified or identifiable
  • coded
  • anonymized
  • anonymous2
  • personal
  • key-coded
  • de-identified
  • nominative
  • pseudonymized
  • irreversibly de-identified
  • reversibly de-identified
  • non-identifiable
  • linked anonymized
  • unidentifiable
  • masked
  • unlinked anonymized
  • encrypted

Category 1: Identified/personal/nominative data are labelled with personal identifiers such as name or identification numbers. Data are directly traceable back to the Data Donor.

Category 2: Pseudonymization/coding/key-coding consists of replacing one attribute (typically a unique attribute) in a record by another. Pseudonymized/coded/key-coded data are labelled with at least one specific code and do not carry any personal identifiers, but an individual is still likely to be identified indirectly; accordingly, pseudonymization/coding/key-coding when used alone will not result in an anonymous data. Pseudonymization/coding/key-coding reduces the linkability of a dataset with the original identity of a Data Donor; as such, it is a useful security measure in genomic research, but it is not a method of anonymization.

Category 3: Anonymization is intended to prevent re-identification. Data must be processed in such a way that it can no longer be used to identify a Data Donor by using all the means likely reasonably to be used by person or entity. An important factor is that the processing must be irreversible to reasonable degree, i.e., anonymized data must not be traceable back to the Data Donor.

Category 4: Anonymous data are never labelled with personal identifiers when originally collected, nor is a coding key generated. Therefore, there is no potential to trace back Data to individual Data Donors. Anonymous data are of extremely limited utility in genomic research.

1Adapted from William W. Lowrance, Learning from Experience Privacy and the Secondary Use of Data in Health Research (London: Nuffield Trust, 2002) at 34; ICH, Guidance for Industry: E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories (April 2008); Article 29 Data Protection Working Party, Opinion 05/2014 on Anonymisation Techniques; Knoppers BM, Saginur M. The Babel of genetic data terminology. Nature Biotechnology 2005; 23(8): 925-927.

2Unlike Lowrance and the Article 29 Working Party, we are of the position that “anonymous” data should be placed in a category separate from “anonymized” data, as the former constitute data that were never individually identifying, whereas the latter constitute data that were, prior to an anonymization process, individually identifying.

Appendix 2: Additional Resources